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The Healthcare Sales & Marketing Network celebrates 28 years serving the medical sales & marketing community.Connecting Medical Sales Reps with MedTech/BioPharma Recruiters and Independent Reps with and New Product LinesConnecting Medical Sales Reps with MedTech/BioPharma Recruiters and Independent Reps with and New Product Lines

Healthcare News Roundup: FDA

 HSMN NewsFeed - 30 Jun 2017
BioMarin Submits Pegvaliase Biologics License Application (BLA) to the U.S. FDA for Treatment of Phenylketonuria (PKU)
Biopharmaceuticals FDA
 HSMN NewsFeed - 30 Jun 2017
Arbor Pharmaceuticals, LLC and Debiopharm International SA Announce U.S. FDA Approval for Triptodur(TM), Triptorelin 6-month Formulation, in the Treatment of Central Precocious Puberty (CPP)
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 Jun 2017
FDA Grants Profounda Inc. Orphan Drug Designation for treatment of Granulomatous Amebic Encephalitis (GAE) with Miltefosine
Biopharmaceuticals FDA
 HSMN NewsFeed - 23 Jun 2017
Lundbeck and Takeda receive Complete Response Letter from the FDA for Trintellix(R) (vortioxetine) sNDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Jun 2017
Additive Orthopaedics Announces FDA Clearance of their Minimally-Invasive, Intramedullary 3D Printed Bunion Correction System for the Extremities Market
Devices Orthopaedic FDA
 HSMN NewsFeed - 21 Jun 2017
Advanced Sterilization Products Receives FDA Clearance For World's First 30-Minute Biological Indicator For Low Temperature H202 Sterilization
Devices FDA
 HSMN NewsFeed - 20 Jun 2017
Hologic Announces FDA Clearance of Aptima(R) Assay to Detect Herpes Simplex Virus 1 & 2
Diagnostics FDA
 HSMN NewsFeed - 20 Jun 2017
BD Receives FDA 510(k) Clearance for New Line of Customizable, 3.0mm Micro-Laparoscopic Instruments
Devices Surgery FDA
 HSMN NewsFeed - 19 Jun 2017
FDA Accepts Amgen's Supplemental Biologics License Application To Expand Indication For XGEVA(R) (denosumab) To Include Multiple Myeloma Patients
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 19 Jun 2017
FDA Accepts Rigel's New Drug Application for TAVALISSE(TM) (fostamatinib disodium) for the Treatment of Chronic ITP
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 Jun 2017
Next Generation Lumbar Fusion Devices by Meditech Spine Aims to Improve Surgical Outcomes, Receives FDA Clearance
Devices Neurosurgery Orthopaedic FDA
 HSMN NewsFeed - 15 Jun 2017
Hologic Receives Expanded FDA 510(k) Clearance to Market Cynosure's SculpSure(R) for Non-Invasive Body Contouring (Lipolysis) of Back, Inner and Outer Thighs
Devices FDA
 HSMN NewsFeed - 13 Jun 2017
TECHLAB(R) Receives FDA 510(k) Clearance To Market E. HISTOLYTICA QUIK CHEK(TM) To Aid Clinicians In The Diagnosis Of Amebiasis Caused By The E. Histolytica Parasite
Diagnostics FDA
 HSMN NewsFeed - 13 Jun 2017
SI-BONE, Inc. Announces FDA Clearance and Full U.S. Commercial Launch of the iFuse-3D(TM) Implant, a Patented, 3D-Printed Next Generation Member of the iFuse Implant System(R)
Devices Neurosurgery Orthopaedic Product Launch
 HSMN NewsFeed - 13 Jun 2017
Zimmer Biomet Holdings Announces Resolution of FDA Warning Letter Related to Its Zhejiang, China Manufacturing Facility
Devices Orthopaedic FDA
 HSMN NewsFeed - 8 Jun 2017
QIAGEN's QuantiFERON(R)-TB Gold Plus gains U.S. FDA approval
Diagnostics FDA
 HSMN NewsFeed - 7 Jun 2017
FDA Approves Hologic's Genius(TM) 3D Mammography(TM) Exam as the Only Mammogram Superior for Women with Dense Breasts*
Devices Radiology Oncology FDA
 HSMN NewsFeed - 6 Jun 2017
Ethicon Announces FDA Approval For SURGICEL(R) Powder Absorbable Hemostat
Devices Surgery FDA
 HSMN NewsFeed - 5 Jun 2017
Novoteris, LLC Receives FDA and Health Canada Clearance to Start a Phase 2 Clinical Trial of Its Thiolanox(R) Nitric Oxide for the Treatment of Cystic Fibrosis
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 5 Jun 2017
BD Receives FDA 510(K) Clearance for Molecular Test for Harmful Intestinal Bacteria Causing Infectious Diarrhea
Diagnostics FDA
 HSMN NewsFeed - 2 Jun 2017
Nexus Pharmaceuticals Receives FDA Approval for Sodium Nitroprusside Injection
Biopharmaceuticals Generics FDA Product Launch
 HSMN NewsFeed - 1 Jun 2017
Roche announces FDA approval of companion diagnostic to identify ALK-positive non-small cell lung cancer patients
Diagnostics Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 1 Jun 2017
GenePOC Announces FDA Clearance for Revogene(TM) Instrument and its GBS LB Test
Diagnostics FDA
 HSMN NewsFeed - 30 May 2017
AMO Pharma Announces FDA Fast Track Designation For AMO-02 For Treatment Of Congenital Myotonic Dystrophy
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 24 May 2017
Sun Pharma Announces US FDA Filing Acceptance of Biologics License Application (BLA) For Tildrakizumab
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 23 May 2017
Ultragenyx Announces Recombinant Human Beta-Glucuronidase Biologics License Application and Marketing Authorization Application Filed and Accepted for Review; FDA Grants Priority Review Status
Biopharmaceuticals FDA
 HSMN NewsFeed - 18 May 2017
Amgen Submits Biologics License Application To The FDA For Erenumab
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 11 May 2017
Xencor's Lead Drug Candidate, XmAb5871, Receives Orphan Drug Designation from FDA for Treatment of IgG4-Related Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 11 May 2017
Rhythm Receives Expanded FDA Breakthrough Therapy Designation for Setmelanotide for Rare Genetic Disorders of Obesity
Biopharmaceuticals FDA
 HSMN NewsFeed - 10 May 2017
Medtronic First to Receive FDA Approval for MR-Conditional Quadripolar Cardiac Resynchronization Therapy-Pacemakers
Devices Cardiology Radiology FDA
 HSMN NewsFeed - 9 May 2017
FDA Grants BAVENCIO(R) (avelumab) Approval for a Common Type of Advanced Bladder Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 9 May 2017
Boston Scientific Receives U.S. FDA Approval For Resonate(TM) Family Of High-Voltage Devices
Devices Cardiology FDA
 HSMN NewsFeed - 8 May 2017
Oncolytics Biotech(R) Inc. Announces FDA Fast Track Designation for REOLYSIN(R) in Metastatic Breast Cancer
Biopharmaceuticals Oncology FDA
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